Combination of Disulfiram Plus Naltrexone to Treat Both Cocaine- and Alcohol-dependent Individuals - 1
Alcohol-Related Disorders, Alcoholism, Cocaine-Related Disorders
About this trial
This is an interventional treatment trial for Alcohol-Related Disorders focused on measuring cocaine
Eligibility Criteria
Inclusion criteria: Meets DSM-IV criteria for both alcohol and cocaine dependence, as determined by the Structured Clinical Interview(SCID-IV) Successful completion of alcohol detoxification (i.e., 3 consecutive days of abstinence from alcohol) Use of at least $100 worth of cocaine in the 30 days prior to enrollment In the past 30 days, Subject used no less than $100 worth of cocaine and drank a minimum of 12 standard alcohol drinks/week (on average), having at least four days in 30 where at least four or more drinks were ingested, as determined by the Timeline Followback (TLFB) - adapted to collect daily cocaine use; Able to commute to the treatment research center Speaks, understands, and writes English Understands and signs the informed consent. Exclusion Criteria: Abstinence from alcohol or cocaine for more than 30 days before signing consent form Current DSM-IV diagnosis of any psychoactive substance dependence other than Alcohol, Cocaine or Nicotine dependence, as determined by the SCID; Evidence of opiate use in the past 30 days as assessed by self-report and intake urine drug screen; History of unstable or serious medical illness, including need for opioid analgesics; Concomitant treatment with phenytoin or from same drug class, lithium, serotonin selective reuptake inhibitors, tricyclic antidepressants, MAOI's or narcotics; 6) Use of any investigational medication within the past 30 days; Severe physical or medical illness such as AIDS, active hepatitis or significant hepatocellular injury as evidenced by elevated bilirubin levels; Severe psychiatric symptoms, e.g., psychosis, suicidal or homicidal ideation or mania; Female patients who are pregnant, nursing, or not using a reliable method of contraception. Acceptable methods of birth control include: barrier (diaphragm or condom) with spermicide, intrauterine progesterone contraceptive system, levonorgestrel implant, medroxyprogesterone acetate contraceptive injection, oral contraceptives.
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Placebo Comparator
Naltrexone
Disulfiram
Naltrexone and Disulfiram
Placebo
Naltrexone
Disulfiram
Naltrexone and Disulfiram
Placebo